BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3922441 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03152
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION PROCEDURE AT USING RHBMP-2/ACS ON (B)(6) 2008 CONSISTING OF THORASCOPIC SURGERY WITH ENDOSCOPIC INSTRUMENTATION AND STAPLING UNILATERALLY ON THE RIGHT VERTEBRAL BODIES FROM T5 TO T12. PRIOR TO THE FIRST SURGERY, IT WAS REPORTED THAT THE PATIENT'S LOWER SPINE WAS STRAIGHT AND THERE WAS NO INDICATION THAT IT WAS BEGINNING TO CURVE. POST OP THE PATIENT WAS REPORTED TO HAVE DEVELOPED ADOLESCENT IDIOPATHIC SCOLIOSIS. THE SURGEON RECOMMENDED A SECOND SURGERY. ON (B)(6) 2011 THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT T3-L2 WITH SPINAL INSTRUMENTATION USING RHBMP-2/ACS. FURTHER FOLLOWING THE SURGERY, THE PATIENT BEGAN TO HAVE PROBLEMS WITH HER SACROILIAC JOINT POPPING IN AND OUT OF PLACE OF PLACE. THE PATIENT REPORTABLY IS UNABLE TO PARTICIPATE IN CHEERLEADING, WHICH CAUSES HER TO BE DEPRESSED AT TIMES AND HER PAIN IS REPORTED TO HAVE WORSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400497 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Required Intervention